The FDA recently approved additional changes to the label of the Ortho Evra birth control patch to include results from a new epidemiology study that suggests that users of the patch are at higher risk for developing serious blood clots than those taking birth control pills. These dangerous blood clots are known as venous thromboembolism (VTE), which can lead to pulmonary embolism. The findings support earlier studies further reinforcing elevated risks of VTE associated with the patch.
The Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson and Johnson, the makers of the patch, conducted the study that prompted the labeling changes. In September of 2006 the FDA advised the label of Ortho Evra to warn an elevated risk of VTE based on two studies.